MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR

Model Number NEU_INS_STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Unspecified Infection (1930)

Event Date 07/08/2015

Event Type  Injury  

Manufacturer Narrative

This value is the average age of the patients reported in the article as specific patients could not be identified.The gender of the patients involved in these events is unknown as the article did not disclose that information.It was noted that 10 males and 10 females were included in the study.Please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.The device was used for an off label indication in some cases, as it was used to treat depression in an unknown number of patients.Concomitant medical products: product id: neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator.Product id: neu_unknown_lead, lot# unknown, product type: lead.(b)(4).

Event Description

Widge, a.S., licon, e., zorowitz, s., corse, a., arulpragasam, a.R., camprodon, j.A., cusin, c., eskandar, e.N., deckersbach, t., dougherty, d.D.Predictors of hypomania during ventral capsule/ventral striatum deep brain stimulation.The journal of neuropsychiatry and clinical neurosciences.2015.Doi: 10.1176/appi.Neuropsych.15040089) summary: deep brain stimulation (dbs) of the ventral capsule/ventral striatum (vc/vs) is a novel therapy for neuropsychiatric disorders.Hypomania is a known complication of vc/vs dbs, but who is at risk is less understood.Factors such as family history, combined with details of dbs programming, might quantify that risk.The authors performed an iterative modeling procedure on a vc/vs dbs patient registry to identify key predictors.Hypomania was less common for men and for patients stimulated on the ventral right contact.It was more common with right monopolar stimulation.These findings may help to establish decision rules to reduce complications of vc/vs dbs.Reported events: one patient with ventral capsule/ventral striatum (vc/vs) deep brain stimulation (dbs) for a neuropsychiatric indication experienced an infection requiring one implantable neurostimulator (ins) to be explanted.Nine patients with ventral capsule/ventral striatum (vc/vs) deep brain stimulation (dbs) for neuropsychiatric indications experienced hypomania.Among the nine patients, there were a total of 12 episodes of hypomania occurring among 428 visits to the health care provider (hcp).Hypomania was managed by briefly interrupting dbs or substantially decreasing stimulation amplitude and, in most cases, an anticonvulsant or antipsychotic drug was also prescribed.It was noted that the hypomania was considered a risk regardless of the patient's clinical phenotype, but was correlated with monopolar stimulation on the right side only.The source literature included the following device specifics: lead model 3391 or lead model 3387 further information has been requested; a supplemental report will be submitted if additional information is received.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5206976
• MDR Text Key: 30577624
• Report Number: 3007566237-2015-03228
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00044 YR